TELE-CARDIO: Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05485532
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 2
• Anticipated Duration (Months): 84
• Patients Per Site: 500
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

Development and validation of a telemonitoring system for high-risk cardiovascular patients.

The main purpose of this study is to investigate the beneficial effect of continuous telemonitoring in patients with cardiovascular diseases in different clinical settings (hospitalized patients, ambulant patients, patients during cardiac rehabilitation,...) Beside established risk parameters such as HRV (heart rate variability) and DC (Deceleration Capacity) new risk stratification models should be established from the continuously recorded biosignals.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: Telemonitoring System using Cosinuss° Two and/or Garmin Vivoactive 4

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2028

Outcome Measures

Primary Outcome Measures

1. occurence of combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure [from inclusion to end of study (max. 3 years)]

Secondary Outcome Measures

1. occurence of all cause mortality [from inclusion to end of study (max. 3 years)]

2. occurence of cardiovascular mortality [from inclusion to end of study (max. 3 years)]

3. occurence of stroke [from inclusion to end of study (max. 3 years)]

4. occurence of myocardial infarction [from inclusion to end of study (max. 3 years)]

5. number of patients with hospitalization due to decompensated heart failure [from inclusion to end of study (max. 3 years)]

6. number of patients with hospitalization due to other cardiovascular condition [from inclusion to end of study (max. 3 years)]

7. number of patients admitted to intensive care unit [from inclusion to end of study (max. 3 years)]

8. number of days with successful telemonitoring [from inclusion to end of study (max. 3 years)]

Other Outcome Measures

1. Cardiac Autonomic Function [from inclusion to end of study (max. 3 years)]

   Heart Rate Variability (HRV), Deceleration Capacity (DC), Periodic Repolarization Dynamics (PRD), Baroreflex Sensitivity, ...

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• decidable male and female patients > 18 years of age

• cardiovascular disease with at least one of the following criteria:

• LVEF ≤ 40%

• cardiac autonomic dysfunction

• St. p. myocardial infarction

• St. p. cardiopulmonary resuscitation

• St. p. pulmonalartery embolism

• St. p. decompensated heart failure

• Informed consent for participation in the clinical trial

Exclusion Criteria:

• missing informed consent

• pregnant and breast-feeding women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie	Innsbruck	Tyrol	Austria	6020
2	Reha Zentrum Münster	Münster	Tyrol	Austria	6232

Sponsors and Collaborators

• Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Univ. Prof. Dr. Axel Bauer, Director of Department for Internal Medicine III - Cardiology and Angiology, Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT05485532
• Other Study ID Numbers: 1282/2020
• First Posted: Aug 3, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Aug 3, 2022